Current Treatment Options for Acute Ischemic Stroke
Each year approximately 800,000 people in the United States experience a stroke, 200,000 of these strokes are recurrent strokes. The overwhelming majority of strokes are ischemic in nature, meaning a blockage of blood flow in/to the brain. Treatment options for ischemic strokes are limited such that approximately 80%* of these patients have no treatment option other than supportive care. DM199 is being studied as a potential therapeutic option to help these patients.
Currently, the only approved therapeutic available to treat acute ischemic stroke patients is Activase® (Alteplase), a tissue plasminogen activator sometimes referred to as “tPA,” which is intended to dissolve the clot causing the blockage of blood flow. However, tPA must be administered within three (3) hours of the onset of stroke symptoms, per its approved label and may not be administered to patients that have a current risk of intracranial hemorrhage (bleeding).
DM199’s Potential Role in Stroke Therapy
DM199 is a recombinant (synthetic) form of a naturally occurring protein called human tissue kallikrein-1 (KLK1). KLK1 is produced primarily in the kidneys, pancreas and salivary glands. KLK1, which is part of the kallikrein-kinin system, plays an important role in the regulation of local blood flow and vasodilation (the widening of blood vessels which decreases blood pressure) in the body, as well as an important role in mitigating inflammation and oxidative stress (an imbalance between potentially damaging reactive oxygen species, or free radicals, and antioxidants in the body). With age, the body’s ability to produce KLK1 may be reduced. KLK1 levels are often low in patients who have experienced a stroke and/or are at risk of a recurrent stroke.
Treatment with DM199 is intended to both improve the physical recovery from an ischemic stroke and reduce the risk for a recurrent stroke. We believe that DM199 works at the level of damaged cerebral tissues to inhibit the inflammation at the site of the blockage, thereby preventing the spread of ischemia (depravation of blood flow) to the surrounding healthy tissue and to improve the overall health of the inner lining (called the endothelium) of cerebral arteries. We believe that DM199 may further reduce the risk of a recurrent stroke as the improvement in the overall health of the endothelium may stimulate the coverage of arterial plaque by local endothelial cells and thereby prevent that plaque from breaking free and causing an additional blockage (stroke).